Companies will work together on critical components that can accelerate client-sponsored validation programs through downstream drug development
FREMONT, Calif. and DURHAM, N.C. – October 11, 2021– Eurofins DiscoverX Products, LLC (Eurofins DiscoverX), an industry leader in assays for drug discovery, development, and QC lot release, announced today the expansion of its Bioassay Certification Program through its certification of KBI Biopharma, Inc. (KBI), a JSR Life Sciences company. KBI is among a specialized group of companies enabled to design workflows and implement Eurofins DiscoverX cell-based assays for multiple client-sponsored validation programs using DiscoverX’s PathHunter® technology platform to deliver highly reproducible potency lot release assays under GLP/GMP conditions.
“We are pleased to receive this certification from Eurofins DiscoverX and to be part of the important work the company is doing to fully leverage the utility of functional cell-based assays in biologics drug development,” said Dirk Lange, President and CEO, KBI Biopharma. “This collaboration reflects KBI’s commitment to rapidly accelerate each client’s drug development program, and we look forward to working with DiscoverX to offer the best scientific solutions to provide world-class results in downstream drug development.”
Demonstrations of potency with specialized, relevant cell-based assays are an integral component of the drug development process. Drug developers must prove that their product candidates are safe and effective (potent). With potency assays playing a critical part of this process, regulators often require the use of functional, cell-based mechanism of action (MOA)-reflective assays that mimic a physiologically relevant environment for potency lot-release studies. The simplicity of the Eurofins DiscoverX PathHunter assay platform, coupled with its broad menu of assays, makes it an attractive platform for pharma and biotech companies to advance their molecules toward regulatory filings.
The advantage of expanding the Bioassay Certification Program, Eurofins DiscoverX leaders say, is that it offers a potent new tool in meeting the needs of biopharma clients seeking CROs and CDMOs that can run its bioassay potency assays when moving their drug product downstream through the development process. Currently, Eurofins DiscoverX includes over 24 qualified bioassays and 36 target-based bioassays that are implemented in global pharma and biotech companies.
The program offers a trusted partner to organizations looking for long-term support to accelerate biologics projects.The companies share a commitment to technical excellence and to doing everything we can to help clients.
KBI Biopharma earned the certification by demonstrating its proficiency in advancing programs for potency under GMP conditions,using the Eurofins DiscoverX PathHunter assay platform, including the successful transfer of multiple client-sponsored GMP validated programs. To earn the certification KBI personnel received training to ensure highly reproducible, cell-based potency lot-release assays for complex biologics.
For more information on the Eurofins DiscoverX certification program, visit www.discoverx.com/cro-certification.
For drug discovery and development scientists, Eurofins DiscoverX is the trusted product solutions provider that can accelerate drug discovery programs with confidence with qualified reagents, cell lines, and assays ready to run today. Eurofins DiscoverX develops and manufactures cutting edge assays, stable cell lines, membrane preps, enzymes, and reagents for drug discovery and development from our three R&D and manufacturing centers of excellence – San Francisco Bay Area,California; St. Louis, Missouri; and Poitiers, France.Rediscover how Eurofins DiscoverX ‘s expertise and trusted products accelerate discovery programs and enable clients through testing phases with confidence. With end-to-end support every step of the way for your programs from Discovery to Q.C. lot release. Eurofins DiscoverX is the products brand of Eurofins Discovery, the industry’s leading drug discovery products and services provider. For more information, visit www.discoverx.com.
KBI Biopharma, a JSR Life Sciences company, is an award-winning biopharmaceutical contract services organization providing fully integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of its 300+ client partners, KBI works closely to personalize and rapidly accelerate drug development programs. Built upon a foundation of world-class analytical capabilities, KBI delivers efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. KBI has locations in Durham and Research Triangle Park (NC), Boulder and Louisville (CO), The Woodlands (TX), Geneva, Switzerland, and Leuven, Belgium. More information is available at www.kbibiopharma.com.